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Agenzia Italiana del Farmaco
Ricerca AIFA
List of titles Note Informative Importanti
Direct communication with healthcare professionals on Veoza (fezolinetant) Highlights News
Veoza (fezolinetant): risk of drug-induced liver injury and new recommendations on monitoring of liver function before and during treatment.
Mon Jan 13 00:00:00 CET 2025 Safety of medicinal productsDirect communication with healthcare professionals on Alofisel (darvadstrocel) Highlights News
Alofisel (darvadstrocel): Withdrawal from the EU market as its clinical benefit is no longer demonstrated to justify its continued use.
Thu Dec 19 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on Metamizole-containing medicines Highlights News
Metamizole-containing medicines: important measures to minimise the serious outcomes of known risk of agranulocytosis.
Mon Dec 09 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on Thiocolchicoside-containing medicines for systemic use Highlights News
The contraindications of use for thiocolchicoside-containing medicines for systemic use have been updated, and the contraceptive measures for female and male patients have been extended.
Mon Oct 28 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on medicines containing 5-fluorouracil Highlights News
Medicines containing 5-fluorouracil (i.v.): In patients with moderate or severe renal impairment, phenotyping for dihydropyrimidine dehydrogenase (DPD) deficiency by measuring blood uracil levels should be interpreted with caution
Thu Oct 24 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on Medrossiprogesterone acetato Highlights News
Medroxyprogesterone acetate: Risk of meningioma and measures to minimise this risk.
Thu Oct 10 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on Oxbryta (voxelotor) Highlights News
Oxbryta (voxelotor): Suspension of EU marketing authorisation.
Mon Oct 07 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on Glatiramer acetato Highlights News
Glatiramer acetate: Anaphylactic reactions may occur months up to years after treatment initiation.
Wed Aug 21 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on Ocaliva (obeticholic acid) Highlights News
Ocaliva (obeticholic acid): recommendation for revocation of the marketing authorisation in the European Union due to unconfirmed clinical benefit.
Wed Jul 31 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on CAR-T anti-CD19 o anti-BCMA Highlights News
Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta (CD19- or BCMA-directed CAR T-cell therapies): Risk of secondary malignancy of T-cell origin.
Thu Jul 18 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on Manidipine-based medicinal Highlights News
Manidipine-based medicinal products: risk of the development of a cloudy peritoneal effluent associated with the use of manidipine in peritoneal dialysis patients.
Thu Jul 18 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on suspension of the marketing authorisations of medicinal products containing hydroxyprogesterone caproate Highlights News
Following the conclusion of the review, a DHPC was prepared regarding the suspension of the marketing authorization for medicinal products containing hydroxyprogesterone caproate.
Wed Jul 17 00:00:00 CEST 2024 Safety of medicinal productsDirect communication with healthcare professionals on chiormadinone acetate/ethinylestradiol Highlights News
Combined hormonal contraceptive (CHC) – chiormadinone acetate/ethinylestradiol Slightly increased risk of venous thromboembolism in women using chlormadinone acetate and ethinylestradiol containing combined hormonal contraceptives.
Fri Mar 22 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on Paxlovid Highlights News
Paxlovid (nirmatrelvir; ritonavir): reminder of life-threatening and fatal drug-drug interactions with certain immunosuppressants, including tacrolimus.
Thu Mar 21 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on Oral Retinoids (acitretin, alitretinoin, and isotretinoin) Highlights News
Oral Retinoids (acitretin, alitretinoin, and isotretinoin): Reminder of restrictions to prevent exposure during pregnancy.
Wed Mar 13 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on etoposide-containing medicinal products Highlights News
Etoposide: Risk of infusion-related hypersensitivity reactions when administered with an in-line filter.
Mon Mar 04 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on medicines containing valproate Highlights News
Valproate containing medicines: new measures regarding the potential risk of neurodevelopmental disorders in children of fathers treated with valproate in the 3 months prior to conception.
Mon Feb 19 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on pseudoephedrine-containing medicines Highlights News
Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicines.
Mon Feb 12 00:00:00 CET 2024 Safety of medicinal productsDirect communication with healthcare professionals on Atossisclerol Highlights News
AIFA calls to the correct use of the Atossisclerol medicine, in particular the foam formulation.
Wed Nov 29 00:00:00 CET 2023 Safety of medicinal productsDirect communication with healthcare professionals on Omega-3-acid ethyl ester medicines Highlights News
Omega-3-acid ethyl ester medicines: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors.
Wed Nov 08 00:00:00 CET 2023 Safety of medicinal productsTopiramate: new restrictions to prevent exposure during pregnancy Highlights News
DHPC in agreement with the European Medicines Agency (EMA) and AIFA to inform healthcare professionals of the implementation of a pregnancy prevention programme for topiramate-containing medicinal products.
Thu Nov 02 00:00:00 CET 2023 Safety of medicinal productsDirect communication with healthcare professionals on Voxzogo®️ (vosoritide) Highlights News
Voxzogo® (vosoritide): change to administration syringe and needle leading to product administration in Units (U) instead of mL.
Mon Sep 04 00:00:00 CEST 2023 Safety of medicinal productsDirect communication with healthcare professionals on Simponi (golimumab) Highlights News
Simponi (golimumab) 50 mg and 100 mg: Important changes to the injection instructions for the SmartJect Pre-filled Pen.
Wed Aug 09 00:00:00 CEST 2023 Safety of medicinal productsDirect communication with healthcare professionals on GAVRETO (pralsetinib) Highlights News
GAVRETO (pralsetinib): Increased risk for tuberculosis and measures to minimise this risk.
Fri Jun 16 00:00:00 CEST 2023 Safety of medicinal productsDirect communication with healthcare professionals on ADAKVEO (crizanlizumab) Highlights News
The benefit-risk balance of Adakveo is no longer favourable and the marketing authorisation in the EU will be revoked.
Thu Jun 15 00:00:00 CEST 2023 Safety of medicinal products